FDA 510(k) Application Details - K183310

Device Classification Name	More FDA Info for this Device
510(K) Number	K183310
Device Name	Encore System
Applicant	Siesta Medical, Inc 101 Church Street, Suite 3 Los Gatos, CA 95030 US Other 510(k) Applications for this Company
Contact	Michael Kolber Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2018
Decision Date	05/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review